Everolimus(RAD001) For Advanced Renal Cell Carcinoma(RCC)Before Kidney Removal - Full Text View

Sponsor:	Gilad Amiel
Collaborator:	University of Texas Southwestern Medical Center
Information provided by (Responsible Party):	Gilad Amiel, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00831480

Purpose

The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal cell carcinoma - RCC).

Since 2002, Everolimus has been studied in more than 2500 patients with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Various studies, in animals such as in mice with cancer and in humans with cancer have shown that Everolimus can slow the growth of cancer.

Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be resumed at the same dose.

Condition	Intervention	Phase
Kidney Cancer	Drug: everolimus	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Neoadjuvant Everolimus(RAD001)for Advanced RCC Before Cytoreductive Nephrectomy, With Correlative Tumor Studies (Protocol #: 06-08-20-01)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

Drug Information available for: Sirolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Disease progression diagnosed by biopsy [ Time Frame: disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	27
Study Start Date:	April 2011
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 All subjects will take everolimus	Drug: everolimus everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery. Other Names: RAD001 Afinitor

Detailed Description:

Everolimus has significantly improved outcomes following prior therapy. This study is a biomarker driven Phase II trial that will assess the activity of everolimus as first-line therapy for renal cell carcinoma. Following initial kidney tumor biopsy, everolimus is administered for 3-5 weeks before cytoreductive nephrectomy and everolimus is then resumed and continued until tumor progression or intolerable toxicities. Any correlation of tumor tissue biomarker changes from initial biopsy to nephrectomy specimen with long-term progression-free survival will be determined. This trial may enable the identification of factors predictive of significant benefit from everolimus administered as first-line therapy by employing the neoadjuvant therapy paradigm.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced (metastatic) RCC
Histology: clear cell, papillary or chromophobe
3 out 6 risk factors (by MSKCC criteria and one additional criterion: multiple sites of metastasis) or not candidates for or refuse sunitinib.
Must have at least one measurable metastatic site according to RECIST criteria that has not been previously irradiated.
Must be deemed surgical candidates for cytoreductive nephrectomy by the urologist.
Age 18 years of age or older
EGOG PS 0-2
Adequate bone marrow function
Adequate liver function as shown by:
Adequate renal function
Fasting serum cholesterol AND fasting triglycerides within normal limits
Signed informed consent

Exclusion Criteria:

Collecting duct, medullary histologies or sarcomatoid differentiation.
CNS or leptomeningeal metastases.
Inappropriate candidates for cytoreductive nephrectomy or who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
severely impaired lung function
uncontrolled diabetes
active (acute or chronic) or uncontrolled severe infections
liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Ineligible for cytoreductive nephrectomy
Current or prior systemic anticancer therapies (including chemotherapy, antibody based therapy, or investigational drugs)
Other malignancies within the past 3 years except for localized carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or localized prostate cancer with Gleason Score less than 7 treated with radiation or surgery and no evidence of progression.
Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of enrollment
Anticipated major surgery (other than CN) during the course of the study
A known history of HIV seropositivity
Hepatitis C seropositivity
Chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
Immunization with attenuated live vaccines within one week of study entry or during study period
Known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its excipients
Impairment of gastrointestinal function or gastrointestinal disease
Active, bleeding diathesis
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
History of noncompliance to medical regimens
Unwilling to or unable to comply with the protocol including mandated biopsies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831480

Contacts

Contact: Sebrina Tello

713-798-8106

stello@bcm.edu

Locations

United States, Texas
UT Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: James Brugarlos, MD, PhD
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Sub-Investigator: Guru Sonpavde, MD

Sponsors and Collaborators

Gilad Amiel

University of Texas Southwestern Medical Center

Investigators

Principal Investigator:

Gilad E. Amiel, MD

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Gilad Amiel, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00831480 History of Changes
Other Study ID Numbers:	H-23409
Study First Received:	January 27, 2009
Last Updated:	February 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:

Renal cell carcinoma
Everolimus
Neoadjuvant
advanced kidney cancer

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012